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EdgeTemp™ Plus Hydraulic Temporary Restorative Material
EDGE ENDO LLC · Model ETEMPPLUS · UDI-DI 00818365021031
EBG
Prescription
10
510(k) clearances
122
Adverse events (1 deaths)
4
Recalls
183
Facilities
Description
EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation. It is supplied in a 40g jar in white (tooth-like) color and is individually boxed. EdgeTemp™ Plus is a water-based temporary filling material used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-10-09 | Talladium Inc | Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 ( |
| 2009-10-22 | Jeneric/Pentron | Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in |
| 2004-06-07 | Lang Dental Mfg Co, Inc. | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. |
| 2004-06-07 | Lang Dental Mfg Co, Inc. | The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.